Press Release

NeoImmuneTech Received U.S. FDA Clearance of IND Application for Phase 1b/2a Study of Hyleukin-7™ (NT-I7) and KEYTRUDA® (Pembrolizumab) in Relapsed/Refractory Advanced Solid Tumors


January 27, 2020 07:00 AM Eastern Standard Time

ROCKVILLE, Md.--()--NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for the combination of NeoImmuneTech’s Hyleukin-7™ (NT-I7) and Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of patients with relapsed/refractory (R/R) advanced solid tumors. This IND clearance allows NeoImmuneTech to initiate a Phase 1b/2a basket study evaluating this combination in patients with both checkpoint inhibitor (CPI)-treated and CPI-naïve R/R advanced solid tumors.

As a company, we are striving to develop a safe and effective immunotherapy for patients with R/R advanced solid tumors, including those who have not been responsive to single-agent CPIs,” said NgocDiep Le, MD, PhD, Chief Medical Officer and Executive Vice President of NeoImmuneTech. “This clearance marks the next step towards our goal of combining Hyleukin-7 with advanced cancer therapeutics such as pembrolizumab.”

The goal of this study is to establish a recommended dosing regimen and explore the preliminary anti-tumor activity of the combination in patients with both CPI-treated and CPI-naïve R/R tumors. The results of this study will be used to further clinical development of this combination in select tumor types. The study will be led by Aung Naing, MD, FACP, Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.

We are constantly looking for better and safer treatment options for our patients, as only a fraction of them can benefit from currently available immunotherapies,” said Dr. Naing. “This agent has the potential to augment and broaden the reach of current treatments such as pembrolizumab, due to its T cell amplifying mechanism of action. We hope this study yields results helpful for our patients in dire need.”

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

About Hyleukin-7™

Hyleukin-7™ (NT-I7), the only clinical-stage long-acting human IL-7, is uniquely positioned to address unmet medical needs in immuno-oncology. IL-7 is a fundamental cytokine for T-cell development and for sustaining immune response to chronic antigens (as in cancer). Hyleukin-7\'s favorable PK/PD and safety profiles make it an ideal combination partner for immunotherapy standard of care (SOC) such as Checkpoint Inhibitor and CAR-T therapies. Hyleukin-7 is being studied in multiple clinical trials in solid tumors, and being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

About NeoImmuneTech

NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company dedicated to expanding the immuno-oncology frontier with Hyleukin-7 and beyond. NIT is partnering with industry and academic leaders to investigate Hyleukin-7 in combination with various immunotherapeutics. For more information, please visit